MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø48 TWO-HOLES; HIP CEMENTLESS CUP

Model Number	01.32.148DH
Medical Device Problem Codes	Failure to Osseointegrate (1863); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Inadequate Osseointegration (2646)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-jan-2023.Lot 2214622: (b)(4) items manufactured and released on 05-oct-2022.Expiration date: 2027-09-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional devices involved batch reviews performed on 30-jan-2023: liner: mpact 01.32.3239hct flat pe hc liner ø32/cc (k103721) lot 2219354: (b)(4) items manufactured and released on 21-sep-2022.Expiration date: 2027-09-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Ball heads: mectacer 01.29.206 biolox delta ceramic ball head 12/14 ø 32 size l +4 (k112115) lot 2119459: (b)(4) items manufactured and released on 20-apr-2022.Expiration date: 2027-04-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
Event or Problem Description
Revision surgery was performed about 1 month after the primary surgery due to the dislocation of the head from the liner.During the revision, the cup was found to be loose.It is likely that the looseness of the cup caused the joint luxation.Cup, head, liner, and stem revised successfully.The stem was revised only to be able to revise the cup.

• Brand Name: MPACT ACETABULAR SHELL Ø48 TWO-HOLES
• Common Device Name: HIP CEMENTLESS CUP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16378891
• Report Number: 3005180920-2023-00080
• Device Sequence Number: 5708823
• Product Code: LPH
• UDI-Device Identifier: 07630030810732
• UDI-Public: 07630030810732
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 01.32.148DH
• Device Catalogue Number: 01.32.148DH
• Device Lot Number: 2214622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian